{"id":12102,"date":"2023-03-07T11:17:36","date_gmt":"2023-03-07T10:17:36","guid":{"rendered":"https:\/\/semmelweis.hu\/pharmacology\/?page_id=12102"},"modified":"2026-01-30T14:31:09","modified_gmt":"2026-01-30T13:31:09","slug":"pharmacovigilance-in-practice-good-vigilance-practice-2023-october","status":"publish","type":"page","link":"https:\/\/semmelweis.hu\/pharmacology\/en\/education\/postgraduate-courses\/pharmacovigilance-in-practice-good-vigilance-practice-2023-october\/","title":{"rendered":"Pharmacovigilance in practice \u2013 Good Vigilance Practice \u2013 2024. SEPTEMBER"},"content":{"rendered":"

This course is no longer available. Click here<\/a> for information about the upcoming course starting in September 2025.<\/h3>\n

Semmelweis University offers the „Pharmacovigilance in practice \u2013 Good Vigilance Practice” accredited course organized by the Department of Pharmacology and Pharmacotherapy.<\/p>\n

The course provides a wide picture of EU and Hungarian regulations in relation to drug, medical device, and food supplements safety. The lecturers have different backgrounds ensuring that the participants receive the most up-to-date information (Academia, Hungarian National Institute of Pharmacy and Nutrition (NNGYK), leading regional pharmaceutical companies<\/span>)<\/p>\n

Application form:<\/span><\/a><\/h3>\n

\"\"<\/a><\/p>\n

Language:\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 English<\/p>\n

Location:\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Online: Zoom<\/p>\n

Date:\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 2024.09.19 – 2024.09.20<\/p>\n

Price:\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 95 000 HUF<\/p>\n

For registration please fill out the following online application form<\/a>, and\/or contact us via email: pharma.education@semmelweis.hu<\/a><\/p>\n

Please, do not hesitate to contact us (pharma.education@semmelweis.hu<\/a>) in case you need further information or have questions.<\/p>\n

 <\/p>\n

Basic data<\/strong><\/h4>\n\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t
Main title<\/th>Pharmacovigilance in practice \u2013 Good Vigilance Practice<\/th>\n<\/tr>\n<\/thead>\n
Code number<\/td><\/td>\n<\/tr>\n
Semester<\/td>II. semester 2024<\/td>\n<\/tr>\n
Nature<\/td>Optional<\/td>\n<\/tr>\n
Condition<\/td>Qualified program<\/td>\n<\/tr>\n
Organizer<\/td>Semmelweis University, Department of Pharmacology and Pharmacotherapy<\/td>\n<\/tr>\n
Contact person<\/td>Dr. Anik\u00f3 G\u00f6rbe, 2104416\u00a0<\/td>\n<\/tr>\n
Target group<\/td>1. internal medicine | 2. internal medicine angiology | 3. vascular surgery
\n4. pharmacology | 5. gastroenterology | 6. family medicine
\n7. neurosurgery | 8. cardiology | 9. hand surgery
\n10. clinic.lab.exam. (hygiene.) | 11. clinical biochemist | 12. clinical pharmacology
\n13. clinical oncology | 14. thoracic surgery | 15. molecular biological diagnostician
\n16. molecular genetic diagnostics | 17. nephrology | 18. neurology
\n19. neuroradiology | 20. orthopedics | 21. orthopedics and traumatology
\n22. medical laboratory diagnostics | 23. radiology | 24. rehabilitation medicine
\n25. rheumatology | 26. surgery | 27. sports medicine
\n28. heart surgery | 29. traumatology<\/td>\n<\/tr>\n
University<\/td>Vocational and Continuing Education Center of Semmelweis University<\/td>\n<\/tr>\n
Accr.point<\/td>20<\/td>\n<\/tr>\n
Start<\/td>19.09.2024<\/td>\n<\/tr>\n
End<\/td>20.09.2024<\/td>\n<\/tr>\n
Location<\/td>Zoom platform<\/td>\n<\/tr>\n
Days<\/td>2<\/td>\n<\/tr>\n
Course hours<\/td>16<\/td>\n<\/tr>\n
Exam<\/td>yes<\/td>\n<\/tr>\n
Price<\/td>95000 HUF<\/td>\n<\/tr>\n
Application deadline<\/td>13.09.2024<\/td>\n<\/tr>\n
Website (more information about the course)<\/td>https:\/\/semmelweis.hu\/pharmacology\/oktatas\/posztgradualis-tanfolyamok\/a-farmakovigilancia-gyakorlatban-good-vigilance-practice\/<\/td>\n<\/tr>\n
Can participants register on the portal?<\/td>Yes<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n

 <\/p>\n

List of lectures<\/strong><\/h4>\n\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t
Index<\/th>Day<\/th>Appoint.<\/th>Duration (min.)<\/th>Title of the presentation<\/th>Performer<\/th>Semmelweis University, Department of Pharmacology and Pharmacotherapy<\/th>\n<\/tr>\n<\/thead>\n
0.<\/td>19.09.2024 Thursday<\/td>08:45<\/td>15<\/td>Welcoming and introduction Learning outcome<\/td>Dr. M\u00e1ty\u00e1s P\u00e9terv\u00e1ri<\/td>Senior PV Compliance Manager, deputy QPPV; Global Regulatory Science Directorate \u00a0\/ \u00a0Global Patient Safety Department \u00a0\/ \u00a0Global Pharmacovigilance Compliance Unit, Richter Gedeon Plc.<\/td>\n<\/tr>\n
1.<\/td>19.09.2024 Thursday<\/td>09:00<\/td>60<\/td>GVP Modul I \u2013 II Pharmacovigilance systems, Pharmacovigilance system master file
\nSpecialized topic: Management of PSMF, and PVAs<\/td>		Dr. G\u00e1bor Erdei<\/td>GMP\/GDP\/GVP Inspector, Hungarian NCA<\/td>\n<\/tr>\n
2.<\/td>19.09.2024 Thursday<\/td>10:00<\/td>45<\/td>GVP Modul III Inspection<\/td>Hatem Adel Ph.D.<\/td><\/td>\n<\/tr>\n
<\/td>19.09.2024 Thursday<\/td>10:45<\/td>15<\/td>BREAK<\/td><\/td>Aurobindo APL Swift Services (Malta) Ltd.<\/td>\n<\/tr>\n
3.<\/td>19.09.2024 Thursday<\/td>11:00<\/td>30<\/td>GVP Modul IV - audits<\/td>Barbara Reithauser-Ny\u00edri<\/td>Head of Department, Egis Gy\u00f3gyszergy\u00e1r Zrt.<\/td>\n<\/tr>\n
4.<\/td>19.09.2024 Thursday<\/td>11:30<\/td>45<\/td>GVP Modul V - VII - Risk management systems; Periodic safety update report<\/td>Dr. Vikt\u00f3ria Kis<\/td><\/td>\n<\/tr>\n
<\/td>19.09.2024 Thursday<\/td>12:15<\/td>45<\/td>LUNCH BREAK<\/td><\/td>Case management team leader, Egis Gy\u00f3gyszergy\u00e1r Zrt.<\/td>\n<\/tr>\n
5.<\/td>19.09.2024 Thursday<\/td>13:00<\/td>45<\/td>GVP Modul VI \u2013 Management of reports of suspected adverse reactions<\/td>Dr. Krist\u00f3f Kov\u00e1cs<\/td>Semmelweis University, Department of Pharmacology and Pharmacotherapy<\/td>\n<\/tr>\n
6.<\/td>19.09.2024 Thursday<\/td>13:45<\/td>60<\/td>GVP Modul IX \u2013 Signal management<\/td>Dr. M\u00e1ty\u00e1s P\u00e9terv\u00e1ri<\/td><\/td>\n<\/tr>\n
<\/td>19.09.2024 Thursday<\/td>14:45<\/td>15<\/td>BREAK<\/td><\/td>PRAC member, NNGYK<\/td>\n<\/tr>\n
7.<\/td>19.09.2024 Thursday<\/td>15:00<\/td>30<\/td>GVP Modul VIII and X<\/td>Dr. J\u00falia Pall\u00f3s<\/td>PRAC member, NNGYK<\/td>\n<\/tr>\n
8.<\/td>19.09.2024 Thursday<\/td>15:30<\/td>30<\/td>GVP Modul XV and XVI<\/td>Dr. J\u00falia Pall\u00f3s<\/td>Position\/academic degree<\/td>\n<\/tr>\n
Index<\/td>Day<\/td>Appoint.<\/td>Duration (min.)<\/td>Title of the presentation<\/td>Performer<\/td>MTA doctor, Semmelweis University (SU)<\/td>\n<\/tr>\n
9.<\/td>20.09.2024 Friday<\/td>08:45<\/td>45<\/td>Challanges of drug safety considering innovative drug development.<\/td>Prof. Dr. P\u00e9ter Ferdinandy \/Dr. Anik\u00f3 G\u00f6rbe<\/td>university professor\/university associate professor<\/td>\n<\/tr>\n
10.<\/td>20.09.2024 Friday<\/td>9:30<\/td>60<\/td>MDR \u2013 Medical device vigilance, introduction<\/td>Dr. \u00c1gnes Horv\u00e1th<\/td>CE Certiso Ltd.<\/td>\n<\/tr>\n
<\/td>20.09.2024 Friday<\/td>10:30<\/td>15<\/td>BREAK<\/td><\/td><\/td>\n<\/tr>\n
11.<\/td>20.09.2024 Friday<\/td>10:45<\/td>45<\/td>Future data sources for pharmacovigilance use<\/td>Maurizio Sessa<\/td><\/td>\n<\/tr>\n
12.<\/td>20.09.2024 Friday<\/td>11:30<\/td>45<\/td>Artificial intelligence and drug safety<\/td>Jan Petracek<\/td>Institute of Pharmacovigilance<\/td>\n<\/tr>\n
<\/td>20.09.2024 Friday<\/td>12:15<\/td>45<\/td>LUNCH BREAK<\/td><\/td><\/td>\n<\/tr>\n
13.<\/td>20.09.2024 Friday<\/td>13:00<\/td>45<\/td>Ecopharmacovigilance<\/td>Joan Dsouza<\/td>ISOP<\/td>\n<\/tr>\n
14.<\/td>20.09.2024 Friday<\/td>13:45<\/td>45<\/td>Engagement of HCP for pharmacovigilance<\/td>Dr. M\u00e1t\u00e9 \u00c1d\u00e1m Bal\u00e1zs<\/td>Semmelweis University<\/td>\n<\/tr>\n
<\/td>20.09.2024 Friday<\/td>14:30<\/td>15<\/td>BREAK<\/td><\/td><\/td>\n<\/tr>\n
15.<\/td>20.09.2024 Friday<\/td>14:45<\/td>45<\/td>Pharmacovigilance map of CEE and Balkan region<\/td>Dr. M\u00e1ty\u00e1s P\u00e9terv\u00e1ri<\/td>Semmelweis University, Department of Pharmacology and Pharmacotherapy<\/td>\n<\/tr>\n
16.<\/td>20.09.2024 Friday<\/td>15:30<\/td>45<\/td>Latest scientific pharmacovigilance advancements<\/td>Dr. Szandra Marton<\/td>Semmelweis University, Department of Pharmacology and Pharmacotherapy<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n

 <\/p>\n

Vocational college(s)<\/strong><\/h4>\n\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t
Numb.<\/th>Vocational college(s)<\/th>\n<\/tr>\n<\/thead>\n
1.<\/td>Internal medicine, endocrinology, diabetes and metabolic diseases<\/td>\n<\/tr>\n
2.<\/td>Angiology and vascular surgery<\/td>\n<\/tr>\n
3.<\/td>Clinical Pharmacology<\/td>\n<\/tr>\n
4.<\/td>Gastroenterological and hepatological<\/td>\n<\/tr>\n
5.<\/td>Home medicine<\/td>\n<\/tr>\n
6.<\/td>Neurosurgery<\/td>\n<\/tr>\n
7.<\/td>Cardiology<\/td>\n<\/tr>\n
8.<\/td>Traumatology and hand surgery<\/td>\n<\/tr>\n
9.<\/td>Medical laboratory<\/td>\n<\/tr>\n
10.<\/td>Oncology and radiation therapy<\/td>\n<\/tr>\n
11.<\/td>Surgery<\/td>\n<\/tr>\n
12.<\/td>Nephrology and dialysis<\/td>\n<\/tr>\n
13.<\/td>Neurological<\/td>\n<\/tr>\n
14.<\/td>Radiological<\/td>\n<\/tr>\n
15.<\/td>Orthopedic<\/td>\n<\/tr>\n
16.<\/td>Rehabilitation, physical medicine and medical aids<\/td>\n<\/tr>\n
17.<\/td>Rheumatology<\/td>\n<\/tr>\n
18.<\/td>Sports health<\/td>\n<\/tr>\n
19.<\/td>Heart surgery<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n

 <\/p>\n

Download PDF<\/a><\/h3>\n","protected":false},"excerpt":{"rendered":"

This course is no longer available. Click here<\/a> for information about the upcoming course starting in September 2025. Semmelweis University offers the „Pharmacovigilance in practice \u2013 Good Vigilance Practice” accredited course organized by the Department of Pharmacology and Pharmacotherapy. The course provides a wide picture of EU and Hungarian regulations in relation to drug, medical device, and …<\/p>\n","protected":false},"author":101941,"featured_media":0,"parent":974,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"template-fullwidth.php","meta":{"_acf_changed":false,"footnotes":""},"categories":[750],"tags":[],"class_list":["post-12102","page","type-page","status-publish","hentry","category-past-course"],"acf":[],"_links":{"self":[{"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/pages\/12102","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/users\/101941"}],"replies":[{"embeddable":true,"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/comments?post=12102"}],"version-history":[{"count":3,"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/pages\/12102\/revisions"}],"predecessor-version":[{"id":15309,"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/pages\/12102\/revisions\/15309"}],"up":[{"embeddable":true,"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/pages\/974"}],"wp:attachment":[{"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/media?parent=12102"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/categories?post=12102"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/tags?post=12102"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}